Bioequivalence study of Ezetimibe 10 mg Tablet, Ezista manufactured by PT Amarox Pharma Global in comparison with Ezetimibe 10 mg Tablet, Ezetrol ® manufactured by MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico; Packed by Schering – Plough Labo N.V., Belgium; Registered by PT Merck Sharp Dohme Pharma Tbk Pasuruan, Jawa Timur
Tahapan Penelitian : Complete
Sponsor:
PT Amarox Pharma Global
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
INA-RGKH7Q4
Tanggal Input Registry : 10-02-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 26-07-2022 |
| Outcome Primer | AUC0-t, Cmax |
| Outcome Skunder | Auc0-inf, Tmax, T1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of Ezetimibe 10 mg Tablet, Ezista manufactured by PT Amarox Pharma Global in comparison with Ezetimibe 10 mg Tablet, Ezetrol ® manufactured by MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico; Packed by Schering – Plough Labo N.V., Belgium; Registered by PT Merck Sharp Dohme Pharma Tbk Pasuruan, Jawa Timur |
| Judul Penelitian Ilmiah | Bioequivalence study of Ezetimibe 10 mg Tablet, Ezista manufactured by PT Amarox Pharma Global in comparison with Ezetimibe 10 mg Tablet, Ezetrol ® manufactured by MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico; Packed by Schering – Plough Labo N.V., Belgium; Registered by PT Merck Sharp Dohme Pharma Tbk Pasuruan, Jawa Timur |
| Jenis Penelitian | Interventional |
| Intervensi | The reference drug was the market available Ezetrol® (ezetimibe 10 mg) tablet manufactured by MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico; Packed by Schering – Plough Labo N.V., Belgium; Registered by PT Merck Sharp Dohme Pharma Tbk Pasuruan, Jawa Timur; Batch number : U019757; manufacturing date : March 2021; expired date : March 2023. The test drug was Ezista (ezetimibe 10 mg) tablet manufactured by PT Amarox Pharma Global; Batch number : 07521H02G; manufacturing date : August 2021; expired date : July 2023. In sampling day subjects took one dose of Ezetimibe products of either formulation (reference or test), as per randomization scheme with 250 mL of water in sitting position. |
| Jumlah Subyek Penelitian | 36 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: a. Willing to participate and agree to sign informed consent, and be able to communicate well with the investigators. b. Healthy female/male subjects as determined by the medical screening assessments. c. Aged 18 - 55 years inclusive. d. Body mass index within the range of 18.00 - 25.00 kg/m2. e. Vital signs, after 10 minutes resting, within the following ranges: (i). Pulse rate: 60 - 90 bpm. (ii). Respiratory Rate: 12 - 20 x/minutes. (iii). Systolic blood pressure: 100 - 129 mmHg. (iv). Diastolic blood pressure: 60 - 84 mmHg. f. Have 12-lead ECG without significant abnormalities. g. Negative results of rapid test antigen Covid-19 at screening process.Exclusion Criteria: a. Participate in another study within 3 (three) months before the first day of study drug administration. b. Pregnant or lactating female (urinary pregnancy test will be performed on screening day and prior study drug administrations on each period). c. Smoker or smoking more than 10 (ten) cigarettes per day. d. Intake of any prescription drug or non-prescription drug within 7 days before the first day of drug administration of this study. e. Blood donation or blood loss of 300 mL (or more) within 3 (three) months before the first day of study drug administration. f. History of drug and/or alcohol abuse or dependency within 12 months before the first day of study drug administration. g. Known hypersensitivity or contraindication to the study drug. h. Any surgical or medical condition (present or history) that might significantly alter the study's absorption, distribution, metabolism, or excretion, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. i. History of any bleeding or coagulative disorders. j. Clinically significant hematology abnormalities. k. Clinically significant urinalysis abnormalities. l. Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). m. History or presence of any liver dysfunction (SGPT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). n. Positive result of HBsAg, HCV, and/or HIV test |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-608/UN2.F1/ETIK/PPM.00.02/2022; S-438/UN2.F1/ETIK/PPM.00.02/2022 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | 078/BE/APR-2022 |
| Contact Person | apt. Nada Mawaddah - Supervisor Klinis PT Biometrik Riset Indonesia |